Kornimate/medical-research-clean huggingface dataset:
assessment of conventional and patient-specific instrumentation in total knee arthroplasty

Conditions: Osteoarthritis

Summary: this study will use a special type of x-ray called radiostereometric analysis (rsa) imaging to determine whether patient-specific instrumentation for total knee arthroplasty (replacement) has an effect on implant loosening compared to conventional instrumentation. secondary objectives will include assessment of post-operative implant alignment, patient satisfaction, operative time and surgical instrument use, cost, and environmental impact.

this is a prospective randomized controlled trial which will enroll 50 patients undergoing total knee replacement surgery. all study patients will undergo an mri prior to surgery. half (25)of these patients will be randomized to have their mri used to develop a patient-specific instrument to be used during their surgery. the other half (25) will have conventional instrumentation (ci) used for their knee replacement surgery. all patients will have the same type of knee implant used for their total knee replacement (genesis ii posterior stabilized (smith \& nephew). patients will not know which group they have been randomized to. for patients randomized into the patient-specific randomization group, if the surgeon is not happy with the patient-specific instrumentation, they have the option to switch to conventional instrumentation at any time during the surgery. • length of operation, number of instruments used, amount of or room waste and number and type of adjustments to the patient specific instrumentation will be tracked. during the surgery, all patients in the study will have tantalum marker beads placed in the bone surrounding their knee replacement. these beads will be used as markers to measure implant fixation over the next two years. all patients will undergo a special type of x-ray imaging called rsa imaging to quantify implant fixation over time. rsa examinations will occur at 6 weeks, 3 months, 6 months, 1 year, and 2 years at the robart's research institute after their standard of care visit with orthopaedic surgeon. model based rsa software used to measure motion of implant components relative to bone markers. all patients will complete our standard outcome measures in the form of surveys completed at their follow-up visits after surgery. •

Eligibility criteria:
inclusion criteria: * undergoing primary total knee replacement surgery * no previous knee hardware (ie.uni-knees, or high tibial osteotomy) * bmi \< 40 * study patients should live within 100 km of our facility to ensure availability for follow-up exclusion criteria: * pregnancy or considering pregnancy * bmi \> 40 * unable to undergo mri screening

Keywords: total knee replacement visionaire
ketamine effect after laparoscopic gastric reduction: a randomized, double-blinded, placebo controlled study

Conditions: Pain; Obesity; Hypoxia

Summary: laparoscopic surgery for gastric reduction is frequently associated with high levels of postoperative pain. postoperative pain is very often treated with opioids. however large doses of opioids can result in respiratory depression with hypoxemia especially in high risk patients with obstructive sleep apnea. since a large group of patients undergoing surgery for gastric reduction surgery also have obstructive sleep apnea, it is expected that these patients are also at high risk for postoperative respiratory depression and hypoxemia. intraoperative ketamine has been used as an effective multimodal agent to reduce postoperative pain. however, ketamine alone has not been examined to improve postoperative pain outcomes in patients undergoing gastric reduction surgery. more importantly, it is unknown if the use of intraoperative ketamine can lead to better overall quality of recovery in the same patient population. in addition, ketamine has been shown to improve ventilation but it remains to be determined if the intraoperative use of ketamine will result in less postoperative hypoxemic events. the main objective of the current investigation is to examine the effect of intraoperative ketamine on postoperative quality of recovery after gastric reduction surgery. the investigators hypothesize that subjects receiving ketamine will have a greater global quality of recovery score than the ones receiving saline.


Eligibility criteria:
inclusion criteria: * age 18-64 * surgery: laparoscopic gastric reduction (gastric sleeve or gastric bypass) * asa physical status classification i, ii, iii * body mass index \>35kg/m2 * fluent in english exclusion criteria: * history of allergy to protocol medications * history of chronic opioid use * pregnant patients * drop out: conversion to an open surgical route, patient or surgeon request.

Keywords: quality of recovery 40 questionaire pain hypoxia gastric surgery obesity ketamine
evaluation of the clinical effectiveness of bioactive glass (s53p4) in the treatment of tibia and femur non-unions

Conditions: Pseudoarthrosis of Bone

Summary: abstract background: treatment of non-union remains challenging and often necessitates augmentation of the resulting defect with an autologous bone graft (abg). abg is limited in quantity and its harvesting incurs an additional surgical intervention leaving the risk for associated complications and morbidities. therefore, artificial bone graft substitutes that might replace autologous bone are needed. s53p4-type bioactive glass (bag) is a promising material which might be used as bone graft substitute due to its osteostimulative, conductive and antimicrobial properties. in this study, the investigators plan to examine the clinical effectiveness of bag as a bone graft substitute in masquelet therapy in comparison with present standard masquelet therapy using an abg with tricalciumphosphate to fill the bone defect. methods/design: this randomized controlled, clinical non-inferiority trial will be carried out at the department of orthopedics and traumatology at heidelberg university. patients who suffer from tibial or femoral non-unions with a segmental bone defect of 2-5 cm and who are receiving masquelet treatment will be included in the study. the resulting bone defect will either be filled with autologous bone and tricalciumphosphate (control group, n = 25) or bag (s53p4) (study group, n = 25). subsequent to operative therapy, all patients will receive the same standardized follow-up procedures. the primary endpoint of the study is union achieved 1year after surgery. discussion: the results from the current study will help evaluate the clinical effectiveness of this promising biomaterial in non-union therapy. in addition, this randomized trial will help to identify potential benefits and limitations regarding the use of bag in masquelet therapy. data from the study will increase the knowledge about bag as a bone graft substitute as well as identify patients possibly benefiting from masquelet therapy using bag and those who are more likely to fail, thereby improving the quality of non-union treatment.


Eligibility criteria:
inclusion criteria: * pseudarthrosis of the tibia or femur * bone defect \< 5 cc * surgical treatment with masquelet technique exclusion criteria: * age under 18 * disagreement * patients who require amputation of the affected limb
magnesium sulfate; postoperative nausea and vomiting; laparoscopic surgery

Conditions: Gynecologic Disease

Summary: postoperative nausea and vomiting (ponv) is commonly accompanied in patients undergoing surgery under general anesthesia. the patients undergoing laparoscopic gynecologic surgery have multiple risk factors for developing ponv such as female gender, nonsmoker, postoperative opioids, and laparoscopic surgery. thus, it is important to prevent ponv in these patients.

magnesium is a n-methyl-d-aspartate (nmda) antagonist that is known to be effective in reducing opioid consumption and controlling postoperative pain. this opioid reducing effect can be associated with reduction of the incidence of ponv. however, the effect of magnesium on preventing ponv have not been investigated before. thus, the investigators hypothesized that intraoperative infusion of magnesium will be effective in preventing ponv in patients undergoing laparoscopic gynecologic surgery.

Eligibility criteria:
inclusion criteria: * gynecologic disease * female patients undergoing laparoscopic gynecologic surgery and receiving postoperative fentanyl based intravenous patient controlled analgesia (pca), aged 20-65 years. exclusion criteria: * impaired renal or hepatic function (glutamic oxalacetate transaminase \[got\]/glutamic pyruvate transaminase \[gpt\]\>50, estimated glomerular filtration rate \[egfr\]\<60) * atrioventricular block, myopathies, diabetes, treated with calcium channel blockers * history of receiving antiemetics within 1 day before surgery * history of receiving opioids or non-steroidal anti-inflammatory drugs within 1 week of surgery * drugs or alcohol abuse * patients treated with isoniazid, chlorpromazine, or digoxin * patients who cannot communicated with others or with cognitive dysfunction * patients who cannot read informed consent
pilot trial investigating every other day dosing of oral iron in premature infants (iqonic)

Conditions: Very Low Birth Weight Infant; Premature Infants; Anemia of Prematurity; Iron Deficiency, Anaemia in Children; Extremely Low Birth Weight

Summary: study focuses on determining if daily versus every-other-day (eod) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates

iron is an important component of hemoglobin, and an essential part of erythropoiesis. it is also a necessary micronutrient for rapidly proliferating and differentiating cells and tissues especially in the brain. iron deficiency in infancy has been associated with anemia and impaired neurodevelopmental outcomes that extend into childhood. premature infants are at highest risk for iron deficiency because they are deprived of the iron accretion that occurs in the third trimester of pregnancy, are born with lower iron stores compared to their term counterparts, and have increased utilization and depletion of iron stores with their rapid growth rate. in older populations, eod iron supplementation is as effective as daily iron supplementation in the treatment of iron deficiency anemia, with studies revealing significantly fewer gastrointestinal side effects in those who are on eod iron. adults regulate their iron status through a feedback pathway involving hepcidin whereby iron-sufficient individuals will have upregulated hepcidin, which leads to decreased iron absorption and availability. recent studies have revealed that pediatric patients and premature neonates regulate iron absorption through hepcidin in a similar fashion. though the regulation of iron status through hepcidin has been studied in extremely premature neonates, the clinical effect of eod dosing of iron has not yet been examined in this population. this is a non-inferiority, blinded, randomized control trial designed to investigate if eod iron is comparable to daily iron dosing in achieving iron replete status by reticulocyte hemoglobin measurements in premature infants.

Eligibility criteria:
inclusion criteria: * children (minor \< 18 years of age) * neonates * hospitalized * premature infants who are on full enteral feeds and are started on oral iron * premature infants who completed 26 0/7 to 32 6/7 weeks' gestation at birth exclusion criteria: • infants with known congenital anomalies or chromosomal abnormalities (such as trisomy 18 or trisomy 21), conditions that affect iron metabolism (such as thalassemia or hemochromatosis), bleeding disorders or coagulopathy, and received iron parenterally prior to randomization

Keywords: premature infants iron anemia of prematurity iron deficiency
flair™ delivery system study

Conditions: Constriction, Pathologic

Summary: the objective of this clinical study is to evaluate the performance of the optimized flair™ delivery system.


Eligibility criteria:
inclusion criteria: * the subject is either a male or non-pregnant female ≥ 18 years old. * the subject has been properly informed about the study per irb requirements, and has signed and dated the irb-approved icf. * the subject is willing to comply with the protocol requirements and can be contacted by telephone. * the subject has a synthetic av access graft located in an arm that has been implanted for \> 30 days and has undergone at least one successful dialysis session prior to the index procedure. * angiographic evidence indicates that the subject has a stenosis of \>50% located at the graft-vein anastomosis of the subject's synthetic av access graft. * the target lesion is estimated to be ≤ 7 cm in length by angiography prior to performance of any interventional procedures. * the entire target lesion is located within 7 cm of the graft-vein anastomosis, as verified by angiography, such that approximately 1 cm of the flair™ endovascular stent graft will extend into non-diseased vein and approximately 1 cm but no more than 2 cm of the flair™ endovascular stent graft will extend into non-diseased av graft. * graft diameter at the deployment site is between 5 mm and 8 mm, as verified by angiography. * full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, can be achieved during primary angioplasty. exclusion criteria: * the subject has a life expectancy of \< 6 months. * the presence of a previously placed stent and/or stent graft located in the treatment area. the treatment area is defined as the entire target lesion and 1 cm of landing zone into both non-diseased av graft and non-diseased vein. * the subject has an infected av access graft or other infection. * the location of the target lesion would require that the flair™ endovascular stent graft be deployed fully across the elbow joint. * the location of the target lesion would require that the flair™ endovascular stent graft cross an angle (between the outflow vein and synthetic av access graft) that is \> 90 degrees. * the subject has an uncorrected blood coagulation disorder. * the subject has a known allergy or sensitivity to contrast media which cannot be adequately pre-medicated. * subject is currently enrolled or scheduled to be enrolled in other investigations that conflict with follow-up testing or confounds data in this trial. * the subject has a known hypersensitivity to nickel-titanium.
effectiveness of slow back stroke massage and murrotal quran on fatigue and quality of life of patients undergoing haemodialysis

Conditions: Fatigue; Hemodialysis; Chronic Kidney Disease; Quality of Life

Summary: the study aimed to investigate the effectiveness of slow back stroke massage and murrotal quran on fatigue and quality of life on patients undergoing hemodialysis.


Eligibility criteria:
inclusion criteria: * patients undergoing hemodialysis minimal 6 months exclusion criteria: * patients with hear impairment
trial of a new nusmile zr esthetic primary molar crown

Conditions: Dental Caries

Summary: the hypothesis to be tested is that nusmile zr esthetic primary molar crowns perform similarly to an established stainless steel primary molar crown (3m espe) for restoration of primary molar teeth.

the aim of this study is to clinically evaluate the performance of a new nusmile zr esthetic primary molar crown, compared with 3m espe primary stainless steel crowns (currently the most common full coverage crown for the restoration of primary molars when a crown is necessary)in the restoration of 50 paired, prepared primary first and second molar teeth in the deciduous dentition of child patients.

Eligibility criteria:
inclusion criteria: * be between 3 and 7 years of age * have a minimum of two primary molar teeth, requiring crowns * have a parent or guardian capable of giving written informed consent * have study teeth in occlusion and in contact with adjacent teeth * teeth to be included in the study must have adequate remaining tooth tissue for retention of the nusmile zr crown to allow randomization of treatments to teeth. exclusion criteria: * tooth is considered to be within 36 months of exfoliation * they have a severe / serious childhood illness that requires frequent hospitalization * they have poor general health * they have juvenile periodontitis * patient is unable to return for evaluations / study recalls

Keywords: pediatric primary molars stainless steel crowns
diabeloop for kids

Conditions: Closed Loop; Diabetes Mellitus, Type 1; Young Children (6 to 12 Years Old )

Summary: an open-label, three-center, randomized, two-session, 4 days inpatient and 6-week follow-up home study phase, crossover study comparing diabeloop closed-loop (cl) system and sensor-augmented pump (sap) therapy. the follow-up home study phase will be done only in french centers for a sub study. during this session, patient wearing the closed-loop system will benefit of a 24h/24, 7 d/7, remote monitoring follow-up by specialized nurses, under supervision of a diabetologist. a visualization of glucose cgm curves, insulin delivery, meal and physical activity announcements will be available online through secured website, and the system will send automated message in case of predetermined situations as persistent too high or too low blood glucose (bg). custom settings will be possible by the nurses during the follow-up period.


Eligibility criteria:
inclusion criteria: * prepubescent children (gender: both) aged between 6 to 12 years old (tanner stage 1) at time of screening * type 1 diabetes as defined by who for at least 1 year or confirmed c peptide negative * an insulin pump user for at least 3 months. * subject having a glycosylated hemoglobin (hba1c) blood value \< 9% at time of screening visit-based on analysis from local laboratory within 3 months. * subject having a minimum daily insulin requirement (total daily dose) of greater than or equal to 8 units. * subject and his parent/guardian willing to spend 3-overnight in hospital. * subject willing to wear the system continuously throughout the study * subjects and his parent/guardian must be able to speak and be literate in french or flemish as verified by the investigator exclusion criteria: * children who are in pubertal stage * subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening: - medical assistance (i.e. paramedics, emergency room (er) or hospitalization) - coma - seizures * subject having sever dka in the 6 months prior to screening visit. * known or suspected allergy against insulin * any other physical or psychological disease, or medication likely to interfere with the conduct of the study and interpretation of the study results as judged by the investigator. * subject is unable to tolerate tape adhesive around the sensor or pump placements * subject has a cardiovascular condition which the investigator determines should exclude the subject, i.e. ventricular rhythm disturbance, hypertrophic cardiomyopathy * subject having took any oral, injectable, or intravenous (iv) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or iv glucocorticoids during the study.

Keywords: artificial pancreas
warm-up efficiency by body warmer versus standard procedure in severely traumatized patients

Conditions: Hypothermia; Trauma, Psychological

Summary: study of adult patients with severe all-cause trauma having a body temperature less than 36°celsius (c) that is managed by a mobile emergency service team and oriented towards a vital emergency room. currently two devices are used to warm patients during their care at the scene of an accident: a survival blanket and heating in the emergency vehicle. despite these two devices many patients arrive in hypothermia (body temperature less than 36°c) in emergency departments. the objective of this study is to evaluate the effectiveness of a body warmer associated with standard warming devices on the correction of hypothermia compared to the standard procedure in severely traumatized patients with hypothermia . it is a national multicentric study with 14 participating mobile emergency service centers and hopefully will include 612 patients. the study will be carried out according to a pattern of 28 successive periods of one week each during the winter period (october to april), for a total duration of 7 months. 14 action periods on (warming standard procedure + body warmer) and 14 control periods off (warming standard procedure) will be run in random order for each center.


Eligibility criteria:
inclusion criteria: * major patient with all-cause trauma grade a or b * patient with a trans-tympanic body temperature of less than 36°celsius (c) at primary management by terrestrial or heliport mobile emergency service team. exclusion criteria: * patient initially supported by a pre-hospital medical team who does not participate in the study, * patient with cardiopulmonary arrest at initial pre-hospital medical team management, * patient with bilateral otorrhagia (due to the non-feasibility of trans tympanic temperature), * patient with inguinal crease or subclavicular fossa injury, * patient with severe burn (burnt body surface\> 20%), * patient deprived of liberty including patients with an electronic bracelet.

Keywords: body warmer pre-hospital